The Medicines and Healthcare products Regulatory Agency (MHRA) has today (3\u00a0June 2026) authorised\u00a0the medicine\u00a0resmetirom\u00a0(Rezdiffra) to treat\u00a0adult patients with metabolic dysfunction-associated steatohepatitis (MASH).\u00a0<\/p>\n
MASH is a liver disease where fat builds up in the liver, which can result in inflammation and damage to the liver cells.\u00a0It is\u00a0a result of the progression of nonalcoholic fatty liver disease where liver inflammation, over time, can lead to liver scarring and liver dysfunction.\u00a0<\/p>\n
Resmetirom\u00a0is used in\u202fadults who have experienced inflammation and cell damage, resulting in moderate scarring, consistent with stage 2 fibrosis, or significant scarring, consistent with stage 3 fibrosis.\u00a0<\/p>\n
In patients with MASH, a protein called thyroid hormone receptor beta (THR-\u03b2), in a type of liver cell called hepatocytes, is less activated. The medicine works by binding to and activating THR-\u03b2. By activating this protein in the liver,\u00a0resmetirom\u00a0increases fat breakdown. This reduces the amount of fat stored in the liver which can help reduce inflammation, fibrosis,\u00a0and improve its function.\u00a0<\/p>\n
The\u00a0authorisations, of\u00a0resmetirom\u00a060 mg, 80 mg and 100 mg film-coated tablets, were\u00a0approved under\u00a0the\u00a0International Recognition\u00a0Procedure (IRP)<\/a>.\u00a0\u00a0<\/p>\n Julian Beach, MHRA Executive Director, Healthcare Quality and Access, said:\u00a0\u00a0<\/p>\n \u201cResmetirom\u00a0is the first medicine to be approved for patients with MASH and moderate to advanced liver fibrosis.\u00a0\u00a0<\/p>\n \u201cWe\u2019re\u00a0assured that the\u00a0appropriate regulatory\u00a0standards for the approval of this medicine have been met\u00a0and today\u2019s decision reflects the MHRA\u2019s commitment to ensuring patients can access innovative treatments that make a real difference.\u00a0\u00a0<\/p>\n \u201cAs with any medicine,\u00a0we\u00a0will continue to monitor\u00a0the\u00a0safety and effectiveness of\u00a0resmetirom\u00a0closely.\u201d\u00a0<\/p>\n This approval is supported by evidence from a main study involving 917 adults with MASH and moderate or advanced liver fibrosis who received either\u00a0resmetirom\u00a0or a placebo for 12 months. Depending on the dose, around 26 to 30 per cent of patients receiving\u00a0resmetirom\u00a0achieved MASH resolution with no worsening of fibrosis, compared with 10 per cent on placebo. Additionally, 27 to 29 per cent of those receiving\u00a0resmetirom\u00a0had an improvement in liver fibrosis with no worsening of MASH, compared with 17 per cent on placebo.\u00a0<\/p>\n Resmetirom\u00a0is taken orally.\u00a0The most common side effects of the medicine \u202f(which may affect more than 1 in 10 people) include\u00a0diarrhoea and nausea.\u00a0\u00a0<\/p>\n Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the\u00a0Yellow Card scheme\u00a0website<\/a>\u00a0or by searching the Google Play or Apple App stores for MHRA Yellow Card.\u202f\u00a0<\/p>\n Notes to editors\u202f\u202f\u00a0<\/p>\n These\u00a0new marketing\u00a0authorisations\u00a0were\u00a0granted on\u00a0 3 June 2026 to Madrigal Pharmaceuticals EU Limited.\u00a0<\/p>\n This product was\u00a0submitted\u00a0and approved via the\u00a0International Recognition Procedure (IRP)<\/a>.\u00a0<\/p>\n More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the\u00a0MHRA Products website<\/a>\u00a0within 7 days of approval.\u202f\u202f\u00a0<\/p>\n Metabolic dysfunction-associated steatohepatitis (MASH)\u00a0is a\u00a0result of the progression of nonalcoholic fatty liver disease. For more information,\u00a0visit:\u00a0non-alcoholic\u00a0fatty liver disease – NHS<\/a>\u00a0<\/p>\n The Medicines and Healthcare products Regulatory Agency (MHRA)\u00a0is responsible for\u00a0regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.\u202f All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.\u202f\u202f\u00a0<\/p>\n The MHRA is an executive agency of the Department of Health and Social Care.\u202f\u202f\u00a0<\/p>\n